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Erschienen in:
13.10.2020 | Original Article
Pilot study: pudendal neuromodulation combined with pudendal nerve release in case of chronic perineal pain syndrome. The ENTRAMI technique: early results
Erschienen in: International Urogynecology Journal | Ausgabe 10/2021
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Introduction and hypothesis
Chronic perineal pain syndrome due to pudendal nerve impingement is difficult to diagnose and to treat. All the known treatment options leave room for improvement considering the outcome. Early neuromodulation of the pudendal nerve after its surgical release could improve outcomes.
Objectives
The aim of the study was to evaluate the potential beneficial effect of pudendal neuromodulation combined with release surgery using the ENTRAMI technique (endoscopic transgluteal minimally invasive technique).
Study design
This is a single-center prospective descriptive study. Between March 2019 and March 2020, 16 patients (2 males, 14 females) were included. Data were collected at baseline and 1 month after surgery.
Methods
Patients eligible for inclusion had chronic perineal pain for at least 3 months in the area served by the pudendal nerve. We combined pudendal nerve release with neuromodulation.
Results
At 1 month, the numeric pain rating scale (NPRS) dropped from 9.5 at baseline to 3.5 (p = 0.003). Seventy-six percent of patients showed a global impression of change (PGIC) of > 50% at 1 month, and optimal treatment response (PGIC ≥ 90%) was found in 41% of patients.
Limitations
The drawback of our study was that it was not randomized or blinded. The peripheral nerve evaluation lead (PNE) used could only be implanted for 1 month because of infection risk and is also prone to dislocations and technical failures.
Conclusion
Pudendal nerve liberation by the ENTRAMI technique combined with short-term pudendal neuromodulation seems feasible and promising in treating patients with chronic perineal pain.
Clinical trial number: NCT03880786.